ASH Clinical News ACN_4.14_Full Issue_web | Page 66

#1 PRESCRIBED THERAPY IN FRONTLINE* AND PREVIOUSLY TREATED CLL 1 †
TAKE CONTROL OF CLL/SLL
WITH YOUR FIRST STEP:
IMBRUVICA® (ibrutinib)
Proven results across key effi cacy endpoints: PFS and OS 2
Based on market share data from IMS from November 2016 to February 2018.
Based on market share data from IMS from July 2014 to February 2018.
*
†
CLL
SLL
IMBRUVICA® (ibrutinib) is a kinase inhibitor indicated for the treatment of adult patients with:
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) 2
• CLL/SLL with 17p deletion 2
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Fatal bleeding events have occurred in patients treated with
IMBRUVICA ® . Grade 3 or higher bleeding events (intracranial hemorrhage
[including subdural hematoma], gastrointestinal bleeding, hematuria, and
post-procedural hemorrhage) have occurred in 3% of patients, with fatalities
occurring in 0.3% of 1,011 patients exposed to IMBRUVICA ® in clinical trials.
Bleeding events of any grade, including bruising and petechiae, occurred in
44% of patients treated with IMBRUVICA ® .
The mechanism for the bleeding events is not well understood.
IMBRUVICA ® may increase the risk of hemorrhage in patients receiving
antiplatelet or anticoagulant therapies and patients should be monitored for
signs of bleeding.
Consider the benefi t-risk of withholding IMBRUVICA ® for at least 3 to 7 days pre
and post-surgery depending upon the type of surgery and the risk of bleeding.
Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal)
have occurred with IMBRUVICA ® therapy. Grade 3 or greater infections occurred
in 24% of 1,011 patients exposed to IMBRUVICA ® in clinical trials. Cases of
progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii
pneumonia (PJP) have occurred in patients treated with IMBRUVICA ® . Consider
prophylaxis according to standard of care in patients who are at increased risk
for opportunistic infections.
Monitor and evaluate patients for fever and infections and treat appropriately.
Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia
(23%), thrombocytopenia (8%), and anemia (3%) based on laboratory
measurements occurred in patients with B-cell malignancies treated with single
agent IMBRUVICA ® .
Monitor complete blood counts monthly.
Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred
with IMBRUVICA ® therapy. Grade 3 or greater ventricular tachyarrhythmias
occurred in 0.2% of patients, and Grade 3 or greater atrial fi brillation and atrial
fl utter occurred in 4% of 1,011 patients exposed to IMBRUVICA ® in clinical trials.
These events have occurred particularly in patients with cardiac risk factors,
hypertension, acute infections, and a previous history of cardiac arrhythmias.
Periodically monitor patients clinically for cardiac arrhythmias. Obtain an ECG for
patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness,
syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias
appropriately, and if it persists, consider the risks and benefi ts of IMBRUVICA ®
treatment and follow dose modifi cation guidelines.
Hypertension: Hypertension has occurred in 12% of 1,011 patients treated
with IMBRUVICA ® in clinical trials with a median time to onset of 5 months
(range, 0.03 to 22 months). Monitor patients for new onset hypertension or
hypertension that is not adequately controlled after starting IMBRUVICA ® .
Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive
treatment as appropriate.
Second Primary Malignancies: Other malignancies (9%) including non-skin
carcinomas (2%) have occurred in 1,011 patients treated with IMBRUVICA ® in
clinical trials. The most frequent second primary malignancy was non-melanoma
skin cancer (6%).
Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported
with IMBRUVICA ® therapy. Assess the baseline risk (e.g., high tumor burden) and
take appropriate precautions.
Monitor patients closely and treat as appropriate.
© Pharmacyclics LLC 2018 © Janssen Biotech, Inc. 2018 10/18 PRC-04536